AusPAR: Fluticasone furoate/vilanterol trifenatate

Australian Public Assessment Report

AusPAR

AusPAR: Fluticasone furoate/vilanterol trifenatate [PDF, 2.92 MB]

AusPAR: Fluticasone furoate/vilanterol trifenatate [DOCX, 7.29 MB]

Attachment: Product Information: Fluticasone furoate/vilanterol trifenatate [PDF, 381.41 KB]

Attachment: Product Information: Fluticasone furoate/vilanterol trifenatate [DOCX, 341.31 KB]

Attachment: Extract from the Clinical Evaluation Report: Fluticasone furoate/vilanterol trifenatate [PDF, 5.39 MB]

Attachment: Extract from the Clinical Evaluation Report: Fluticasone furoate/vilanterol trifenatate [DOCX, 17.63 MB]

Device/Product Name

Breo Ellipta

Active ingredients

Fluticasone furoate / vilanterol trifenatate

AusPAR Date

25 June 2014

Published

20 November 2014

Submission Number

PM-2012-01970-3-5

Submission Type

New chemical entity, New combination

Decision

Approved

Product types

Prescription medicines